FDA.report

PURELIFE

Primary DI
D79011901063
Brand
PURELIFE
Company
PURELIFE, LLC
Model
1190106
Catalog number
1190106
Device description
STERILIZATION POUCHES - 7-1/2" X 12"
Published
2017-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D79011901063PackageHIBCC10Not in Commercial Distribution
D79011901061PrimaryHIBCC0
D79011901060Unit of UseHIBCC0

GMDN Terms

TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods

Method

Contacts

PhoneEmail
8777773303scottp@purelifedental.com

Regulatory Flags

DUNS number
828690904
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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D79011549033PureLife Dental115490311549032025-07-08
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D790106840210685020PureOrthoSense10684021068502106840210685022025-03-20
D790106840310685030PureOrthoSense10684031068503106840310685032025-03-20
D790106840410685040PureOrthoSense10684041068504106840410685042025-03-20
D790106840510685050PureOrthoSense10684051068505106840510685052025-03-20
D79010201010PureSkin102010110201012023-09-22
D79010201020PureSkin102010210201022023-09-22
D79010201030PureSkin102010310201032023-09-22
D79010201040PureSkin102010410201042023-09-22
D79010201050PureSkin102010510201052023-09-22
D79010217010PureBliss102170110217012023-09-22
D79010217020PureBliss102170210217022023-09-22
D79010217030PureBliss102170310217032023-09-22
D79010217040PureBliss102170410217042023-09-22
D79010217050PureBliss102170510217052023-09-22
D79010681010PureOnyx106810110681012023-09-22
D79010681020PureOnyx106810210681022023-09-22
D79010681030PureOnyx106810310681032023-09-22
D79010681040PureOnyx106810410681042023-09-22

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